According to the FDA, six words not to utter on FDA inspection day are: “Now, where is that darn document?” (It’s nice the FDA has a sense of humor, at least on paper).
Kidding aside, this is a big-enough issue that the FDA recently offered a seminar to alleviate problems such as:
- Unscanned paper documents
- Confusing naming conventions
- E-mails as documentation
- Non-functional or non-existent SOPs
- Missing documents